BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 2197735 · Received July 29, 2011

    Report

    Report Number
    2027969-2011-01684
    Event Type
    Other
    Date Received
    July 29, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 29, 2011
    Manufacturer
    ALRE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB: DATE: (B)(6) 2011, INRATIO: 1.3, RETEST#1 INRATIO: 1.2, RETEST#2 INRATIO: 1.4. DATE: (B)(6) 2011, INRATIO: 1.4, LAB: 3.7. PT'S TARGET THERAPEUTIC RANGE IS 2.5-3.5. ON (B)(6) 2011, RESULTS DONE WITHIN MINUTES OF EACH OTHER. ON (B)(6) 2011, LAB DRAW WAS DONE 1.2 HOURS AFTER THE METER. COUMADIN DOSE WAS INCREASED AFTER RESULTS ON (B)(6) 2011,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALRE SAN DIEGO, INC. 100071 248203

    Patients

    Seq Age Sex Outcome Treatment
    1 Other